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Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

Sponsor
PharmaKing (Industry)
Overall Status
Completed
CT.gov ID
NCT02637310
Collaborator
(none)
108
Enrollment
2
Arms
3
Duration (Months)

Study Details

Study Description

Brief Summary

A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

Condition or Disease Intervention/Treatment Phase
  • Drug: N02RS1 1200mg
  • Drug: Placebo
 Phase 2

Detailed Description

Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: N02RS1 1200mg

Combination of Broussonetia spp and Lonicera spp

Drug: N02RS1 1200mg
1200mg/day, Three times a day orally, 2 tablets once, 7 days
Placebo Comparator: Placebo

sugar pill

Drug: Placebo
1200mg/day, Three times a day orally, 2 tablets once, 7 days

Outcome Measures

Primary Outcome Measures

  1. BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days [Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients over 19, under 75 of age

  • Patients acute bronchitis, sputum symptoms, BSS over 7 points.

  • Patients acute bronchitis within 7days.

  • Non-pregnant, patients who agree to contraception.

  • Patients who can write diary and available to communicate.

  • Patients voluntarily agreed

Exclusion Criteria:

  • Patients with hypersensitivity to the drug.

  • Patients who have gotten systemic steroid treatment within 4 weeks.

  • Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.

  • Patients who have gotten treatment of mucus solvents or antitussives within 3 days.

  • Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.

  • Patients heart disease, severe kidney, liver disease.

  • The bleeding tendency or immunosuppressed patients.

  • Patients with clinically significant abnormal values.

  • Pregnant women or nursing mothers.

  • Patients alcoholics or drug abuse.

  • Patients taking other clinical trail's medicines within 30 days.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • PharmaKing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PharmaKing
ClinicalTrials.gov Identifier:
NCT02637310
Other Study ID Numbers:
  • PMK-N02RS1_Phase 2B
First Posted:
Dec 22, 2015
Last Update Posted:
Mar 30, 2016
Last Verified:
Mar 1, 2016
Additional relevant MeSH terms:
Bronchitis
Acute Disease

Study Results

No Results Posted as of Mar 30, 2016